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Convex Array Probe

EUP-C524

INSTRUCTION MANUAL

Tokyo

Japan

Q1E-EP0385-6

Notes for operators and responsible maintenance personnel

★

Please read through this Instruction Manual carefully prior to use.

★

Keep this Instruction Manual together with the system with care to make it

available anytime.

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Содержание EUP-C524

Страница 1: ...85 6 Hitachi Ltd 2013 2016 All rights reserved Notes for operators and responsible maintenance personnel Please read through this Instruction Manual carefully prior to use Keep this Instruction Manual together with the system with care to make it available anytime 0123 ...

Страница 2: ... businesses healthcare index html European Representative Hitachi Medical Ultrasound Logistics Zweigniederlassung der Hitachi Medical Systems Europe Holding AG Carl Zeiss Strasse 5 D 72555 Metzingen Germany EU Importer Hitachi Medical Systems Europe Holding AG Address Sumpfstrasse 13 CH 6300 Zug Switzerland Local Distributor ...

Страница 3: ...stions concerning the manual Please contact a service support The following conventions are used throughout the manual to denote information of special emphasis WARNING Warning is used to indicate the presence of a hazard which can cause severe personal injury death or substantial property damage if the warning is ignored CAUTION Caution is used to indicate the presence of a hazard which will or c...

Страница 4: ... Manufacturer Company Name and Address Hitachi Ltd 2 16 1 Higashi Ueno Taito ku Tokyo 110 0015 Japan 81 3 6284 3668 http www hitachi com businesses healthcare index html Authorized Representative in The European Community Hitachi Medical Ultrasound Logistics Zweigniederlassung der Hitachi Medical Systems Europe Holding AG Carl Zeiss Strasse 5 D 72555 Metzingen Germany Keep away from Sunlight Store...

Страница 5: ...nnector Warning dangerous voltage Probe connector Caution Biohazard Probe connector Follow the instruction manual to operate this instrument If not avoided may result in injury property damage or the equipment trouble Probe connector Upper Limit of Temperature The probes that are applicable to Ethylene Oxide Gas Sterilization use symbol of Upper Limit of Temperature 55 degrees Probe connector Do n...

Страница 6: ...nspection for Material Surface 4 3 Operation Procedure 5 4 Cleaning Disinfection and Sterilization 6 4 1 Point of use Pre cleaning 7 4 2 Containment and transportation 7 4 3 Cleaning and disinfection 8 4 4 Drying 10 4 5 Inspection 10 4 6 Packaging 11 4 7 Sterilization 12 4 8 Storage 14 5 Maintenance and Safety Inspection 15 6 Safety Precautions 16 7 Specifications 17 7 1 Probe 17 7 2 Suppliers Lis...

Страница 7: ...sonic waves This system operates under the principles described below 1 When an electric pulse signal is applied from the transmitter to the transducer of the probe the transducer converts electric signals into mechanical vibration energy for emitting pulse shaped ultrasonic waves into the body part liquid or other medium contacting the transducer 2 The emitted ultrasonic waves are reflected by bo...

Страница 8: ...gan 1 4 Composition The probe components of the EUP C524 are as follows 1 Probe EUP C524 1 piece 2 Instruction Manual 1 copy 1 5 Option Needle Guide Bracket EZU PA5C2 1 Needle guide bracket 1 piece 2 Brush 1 piece 3 Spring Spare 2 pieces 4 Instruction Manual 1 copy 5 Biopsy case 1 piece Please refer to the instruction manual of option about the method of handling cleaning and sterilizing the needl...

Страница 9: ...Head Connector Cable Un immersible part IP40 Immersible part This part can be immersed in disinfectant solution and also can be cleaned by water Un immersible part This part should not be immersed in disinfectant solution and also can not be cleaned by water Fig 1 External view of the EUP C524 Applied part ...

Страница 10: ...the instruction manual for the ultrasound diagnostic scanner 2 1 2 Do not attach or connect unauthorized devices or instruments on the probe such as unauthorized biopsy attachments 2 2 Inspection for Material Surface 2 2 1 Visually inspect the surface of the probe and head housing the cable and the connector for any crack scratch or denaturalization If you find any damage do not use the probe and ...

Страница 11: ... 2 The right left orientation mark on the image indicates the direction of the index mark on the probe 4 Use under sterile condition protect the probe by using an appropriate cover is recommended Some Latex material may create allergic reaction Please use allergy free material covers 5 After the use of the probe it should be cleaned and disinfected or sterilized then store it in an adequate place ...

Страница 12: ...ring transportation Levels of reprocessing requirements Depending on the application of the product and with regard to risk evaluation the user has to classify the medical device according to the current Medical Device Directive for processing of medical devices as uncritical semi critical or critical Supporting information concerning this topic is listed in the table below The user is responsible...

Страница 13: ...ntainment and transportation Putting the contaminated equipment into exclusive shock and damage proof container for transportation is recommended It is recommended that instruments are reprocessed as soon as possible and not later than 4 hours after usage Point of use Pre cleaning Manual Cleaning Rinsing after manual cleaning Manual Disinfection Drying Manual cleaning and disinfection Rinsing afte...

Страница 14: ...cturer for the detergent and the disinfectant Manual Cleaning Prepare the detergent solution in a tank with cold water please follow the instructions of the detergent manufacturer regarding application dilution and contact time 1 The temperature of the detergent solution should be between 15 30 C concentration is 1 6 Please note the minimum contact time of the detergent in the manufacturer s instr...

Страница 15: ...with the detergent solution 5 Rinse the probe with running tap water for 1 minute alternatively immerse the immersible part of the probe in a tray filled with deionized water tap water see Fig 3 for 5 min 6 Visually check the outer surface of the probe for cleanness If necessary use magnifying glass for visually check If there is still soil visible repeat all above steps Water Detergent Disinfecta...

Страница 16: ...nstructions Please also consider the material compatibility for the medical device 3 Immerse the immersible part of the probe into the disinfectant see Fig 3 Set a clock to insure the recommended contact time which is 5 minutes 4 Rinse the immersible part of the probe with deionized water for 1 minute alternatively immerse the immersible part of the probe in a tray filled with deionized water see ...

Страница 17: ...ic mesh wires supplied for plasma sterilization and then packed as mentioned above The probe can be packed in a simple or double packing Please note that the size of a sterile barrier should be large enough to be able to pack the equipment leaving sufficient space to seal it completely A sterile barrier should be sealed by an appropriate sealing machine and it is important to confirm that the pack...

Страница 18: ...ime 30 45 minutes Exposure Temperature 122 0 131 0 F equivalent of 50 55 C Sterilant gas 10 EO 90 HCFC Excess pressure 162 200 kPa Exposure time 120 125 min full cycle Post vacuum 8 26 kPa 2 times Aeration Temperature 50 55 C Time min 11 hours Plasma sterilization Sterilization Method Condition Plasma Sterilization STERRAD 50 100S or 200 Short Cycle Plasma Sterilization Sterrad NX or 100NX Standar...

Страница 19: ...Seal the TYVEK Pouch using a heat sealer Ensure that the seal is complete 3 Put the sealed pouch into a tray or plastic mesh wire for sterilization TYVEK Pouch Fig 1 Packaging in the pouch Probe TYVEK Pouch Sealed Fig 2 Sealing Probe Fig 3 Packaging in a tray Probe in the Pouch Tray for sterilization ...

Страница 20: ... Q1E EP0385 4 8 Storage Store the equipment in a cool dustproof dry and dark space to avoid high temperature humidity and direct sunlight Limitations for the time for sterilized equipment belong to package ...

Страница 21: ...ing Disinfection and Sterilization store the probe in a cool and dark space to avoid high temperature humidity and direct sunlight 2 Visually inspect the surface of the probe head the housing the cable and the connector for any crack scratch or denaturalization If you find any damage do not use the probe and immediately contact a service support ...

Страница 22: ... observe any of above mentioned symptoms in your patient during the operation stop the use of latex containing medical devices immediately and take an appropriate treatment to the patient By examination of an early pregnancy the exposure time shall be as short as possible Start examination with acoustic output power set to L Low The probe connector is not water proof Do not allow liquid to contact...

Страница 23: ...e system Depending on production and upgrade status For detailed information contact a service support Classification MDD classification IIa Cleaning Applicable detergents are listed in the suppliers list Disinfection Applicable disinfectants are listed in the suppliers list Sterilization ETO gas sterilization Plasma sterilization Operating conditions Ambient temperature 25 35 C Contact surface te...

Страница 24: ...zymatic detergent Meliseptol HBV Tücher Braun Disinfectant CIDEX plus Johnson Johnson Disinfectant ALKACIDE ALKAPHARM Disinfectant ALKAZYME ALKAPHARM Cleaner Please contact your local distributor for a current version of the Disinfectant Sterilization Method Compatibility for Ultrasound Probe and Accessory List 8 Disposal of the probe Please contact us or the distributor for disposal of the probe ...

Страница 25: ... 19 Q1E EP0385 Fig 7 Dimensions Unit mm E ...

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